BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE FREEDOM

    MDR report key: 1984062 · Received February 10, 2011

    Report

    Report Number
    2954323-2011-01570
    Event Type
    Injury
    Date Received
    February 10, 2011
    Date of Event
    January 11, 2011
    Report Date
    April 29, 2011
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED METER WAS RETURNED AND INVESTIGATED WITH RETURNED TEST STRIPS LOT 1007514. CONTROL SOLUTION TESTING WAS PERFORMED. ALL RESULTS WERE WITHIN RANGE SPECIFICATION AND NO ERRORS WERE OBSERVED. NO NEW ISSUES WERE OBSERVED. THE COMPLAINT IS NOT CONFIRMED. THIS IS A FINAL REPORT.

    Additional Manufacturer Narrative · 1

    CUSTOMER'S PRODUCT HAS BEEN REQUESTED BACK FOR INVESTIGATION AND A SUPPLEMENTAL REPORT WILL BE SENT ONCE NEW INFORMATION IS OBTAINED.

    Description of Event or Problem · 1

    AN ADC CUSTOMER REPORTED RECEIVING AN ERROR 4 MESSAGE ON THEIR FS FREEDOM METER DURING STRIP INSERTION ON (B)(6) 2011 AND WAS UNABLE TO TEST. SHE THEN REPORTED THAT WHILE WALKING TO A STORE THAT SAME DAY SHE EXPERIENCED SYMPTOMS OF HYPOGLYCEMIA, "PASSED OUT" AND SUBSEQUENTLY LOST CONSCIOUSNESS. PARAMEDICS WERE CALLED AND CUSTOMER WAS ADMINISTERED ORAL GLUCOSE GEL ON SCENE AND TRANSPORTED TO A HEALTH CARE FACILITY. CUSTOMER WAS DIAGNOSED WITH HYPOGLYCEMIA AT THE HOSPITAL AND TREATED WITH INTRAVENOUS DEXTROSE. NO ADDITIONAL INFORMATION WAS PROVIDED. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREESTYLE FREEDOM BLOOD GLUCOSE MONITORING SYSTEM NBW 1007514

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R